510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K892323Substantially Equivalent

Seismocardiograph - Scg(tm) 1000 Series

Seismed Instruments, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892323 is the FDA 510(k) clearance record for SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES, a class II device, cleared for Seismed Instruments, Inc. on under FDA product code DSB (Plethysmograph, Impedance). FDA records list 3 510(k) clearances for Seismed Instruments, Inc., from to . As of , FDA records show no recalls naming K892323.

Clearance record

Decision date
Received
(207 days to decision)
Product code
DSB Plethysmograph, Impedance
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Seismed Instruments, Inc. 825 So. 8th St., Suite 320, Minneapolis MN
Third party review
No

Clearances, product code DSB

Trailing 12 months
2 clearances under product code DSB in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSB, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260